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Compound xylocaine cream pharmaceutical composition and preparation method thereof

A technology of lidocaine cream and lidocaine, which is applied in the field of compound lidocaine cream pharmaceutical composition and its preparation, can solve the problems of easy moisture absorption and difficult storage, and achieve moistening of the paste, convenient medication, and dispersion uniform effect

Active Publication Date: 2017-06-09
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Prilocaine free base is needle crystal, melting point 37-38℃, easy to absorb moisture, difficult to store

Method used

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  • Compound xylocaine cream pharmaceutical composition and preparation method thereof
  • Compound xylocaine cream pharmaceutical composition and preparation method thereof
  • Compound xylocaine cream pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1 Preparation of compound lidocaine cream pharmaceutical composition

[0045] Prescription composition (preparation of 10kg cream):

[0046]

[0047] Preparation:

[0048] (1) Preparation of water phase: Weigh carbomer 974P according to the prescription, and measure purified water according to the preparation of 1.2% carbomer 974P aqueous solution, slowly add carbomer 974P to purified water, and stir for more than 1 hour to dissolve completely. Prepare the water phase;

[0049] (2) Preparation of oil phase: take lidocaine and prilocaine in the main pot according to the prescription, stir and mix uniformly at 40-50 ℃, and melt to a transparent liquid to obtain the eutectic of lidocaine and prilocaine; Polyoxyethylene 40 hydrogenated castor oil in the prescription amount is melted at 60°C and added to the eutectic, and stirred evenly to prepare the oil phase for use;

[0050] (3) Prepare 10% sodium hydroxide solution with purified water according to the prescription amoun...

Embodiment 2

[0059] Example 2 Preparation of compound lidocaine cream pharmaceutical composition

[0060] Prescription composition (preparation of 45kg cream):

[0061]

[0062] Preparation:

[0063] (1) Water phase preparation: slowly add the prescribed amount of Carbomer 940 to 18525g purified water, stir for more than 1 hour to completely dissolve to obtain the water phase;

[0064] (2) Preparation of oil phase: take lidocaine and prilocaine in the main pot according to the prescription, stir and mix uniformly at 40-50 ℃, and melt to a transparent liquid to obtain the eutectic of lidocaine and prilocaine; Polyoxyethylene 80 hydrogenated castor oil in the prescription amount is melted at 60°C and added to the eutectic, and stirred to obtain an oil phase for use;

[0065] (3) Prepare 10% sodium hydroxide solution with purified water according to the prescription amount;

[0066] (4) Emulsification: add the remaining purified water to the oil phase prepared in step (2), set the slow stirring and wal...

Embodiment 3

[0068] Example 3 Preparation of compound lidocaine cream pharmaceutical composition

[0069] Prescription composition (preparation of 10kg cream):

[0070]

[0071] Preparation:

[0072] (1) Preparation of water phase: Weigh carbomer 934 according to the prescription, and measure purified water according to the 0.5% aqueous solution of carbomer 934, add carbomer 934 slowly to purified water, and stir for more than 1 hour to dissolve completely. Prepare the water phase;

[0073] (2) Preparation of oil phase: take lidocaine and prilocaine in the main pot according to the prescription, stir and mix uniformly at 40-50 ℃, and melt to a transparent liquid to obtain the eutectic of lidocaine and prilocaine; Polyoxyethylene 80 hydrogenated castor oil in the prescription amount is melted at 60°C and added to the eutectic, and stirred to obtain an oil phase for use;

[0074] (3) Prepare 5% sodium hydroxide solution with purified water according to the prescription amount;

[0075] (4) Emulsifica...

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Abstract

The invention provides a compound xylocaine cream pharmaceutical composition and a preparation method thereof. The pharmaceutical composition is prepared by using effective quantities of xylocaine and prilocaine as main medicinal materials and using polyoxyethylene hydrogenated castor oil, carbomer, sodium hydroxide and purified water as medicinal auxiliary materials. The cream has the advantages of high moisture content, favorable spreadability, low impurity content, high quality and small skin irritation.

Description

Technical field [0001] The invention relates to a compound lidocaine cream pharmaceutical composition and a preparation method thereof, and belongs to the technical field of medicine. Background technique [0002] Local anesthetics refer to drugs that can temporarily and reversibly block the generation and conduction of nerve fiber impulses within a limited range of the body without causing the patient to lose consciousness. [0003] Local anesthetics are divided into the following categories according to their clinical usage: topical anesthesia, spinal anesthesia, infiltration and blocking anesthesia, epidural and caudal anesthesia, etc. General local anesthetics and adrenaline can cause vasoconstriction to increase local drug concentration, prolong and enhance drug effect, and reduce systemic toxicity. [0004] The first local anesthetic used was cocaine, which was officially used in clinical practice in 1884. Cocaine is highly toxic, addictive, and its aqueous solution is unstab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/167A61K47/44A61K47/32A61P23/02
Inventor 赵亮
Owner SICHUAN HAISCO PHARMA CO LTD
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